Is software vital for serialization?
Serialization is not about putting random serial numbers on your merchandise. It requires implementing fool proof SOPs of managing the process. The process is extensive and depends on the level of serialization that needs done.
Simple answer to the question, Yes! Software is extremely vital for serialization.
So now the question comes, Why is it vital?
Different level of operation requires different degrees of the information management. Efficient Data Management, Security, following the SOPs, making spot validations, implementing changes, managing and reporting incidents; are all part of the managing the operation.
Samples Serialized Pharma Unit Cartons
Typically the following processes (to say a few) needs to take place during and after the production of a batch.
- Generating Serial Numbers
- Aggregation
- Reconciliation
- Storing for Regulatory
- Sharing Data with Regulatory
- Disaster Recovery
- Security
- Audit Trail
- Mitigating infiltration/ data pilferage risk
The reason a serialization software is a must is because it allows to management multiple operation in a seamless manner. Management of Multiple processes are just a matter of one click. Serialization operation requires a number of tasks being perform just during the production of the merchandise, let alone going through the QA/QC procedure, sharing information with internal and external stake holders, storing data securely,
Not having a Solution basically means that the serialization data is either not being managed. With the Drug Regulatory Authority Pakistan’s requires that data to be held for 5 years. This makes managing the serialization operation is no less than Data Management nightmare.
If you do not have a solution on board to run a serialization operation, it basically means the information is basically being managed by using Office Automation Tools such as Excel, storing individual CSVs, perhaps even having a Database being run on Microsoft Access. With the amount of data being generated in a serialization operation, mismanagement, misreporting, data pilferage and other data management fiascoes are just a matter of time to happen. Which frankly will not be long before you’ll realize you’re in hot waters (Typically few hours of production is enough!).
